Doxorubicin
Doxorubicin is an anthracycline chemotherapy medicine given by injection or infusion for breast cancer, leukemias, lymphomas, and many other solid tumors, and in a liposomal form for ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 35 clinical label sets within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
How we combine label and product data →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Doxorubicin can seriously damage the heart, sometimes with fatal heart failure, during treatment or months to years afterward. The risk climbs as the total lifetime dose goes up, and it is higher with existing heart disease, prior chest radiation, other anthracycline chemotherapy, or other heart-toxic drugs. Children are at higher risk of delayed heart damage.
If the drug leaks out of the vein during an infusion, it causes severe local tissue damage, so it must never be given into muscle or under the skin. Doxorubicin can also lead to secondary leukemia (AML) or myelodysplastic syndrome, and it can cause severe myelosuppression (low blood counts). The dose should be reduced with liver impairment. It should be given only under the supervision of a doctor experienced in cancer chemotherapy.
Patient information guide — a plain-language walkthrough of Doxorubicin, written from its FDA label.
What Doxorubicin is used for
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Doxorubicin is used for many cancers, and the approved uses differ by product.
- Standard doxorubicin products, including Adriamycin: add-on chemotherapy after surgery for women with breast cancer and lymph node involvement.
- Standard products: acute lymphoblastic leukemia and acute myeloblastic leukemia.
- Standard products: Hodgkin lymphoma and non-Hodgkin lymphoma.
- Standard products: metastatic breast cancer, Wilms’ tumor, neuroblastoma, soft tissue sarcoma, and bone sarcoma.
- Standard products: metastatic ovarian, bladder (transitional cell), thyroid, stomach, and lung (bronchogenic) cancers.
- Liposomal products, including Doxil: ovarian cancer after platinum-based chemotherapy.
- Liposomal products: AIDS-related Kaposi’s sarcoma after other chemotherapy failed or was not tolerated.
- Liposomal products: multiple myeloma, with bortezomib, in people who have not had bortezomib and have had at least one prior therapy.
How Doxorubicin works
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Doxorubicin inserts itself between the building blocks of DNA in cancer cells. This stops them from copying DNA and making RNA. It also traps an enzyme called topoisomerase II on the DNA, causing breaks that lead to cell death.
It also binds to cell membranes and can form reactive molecules called free radicals, which are thought to contribute to its heart toxicity.
Doxorubicin dosage
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Doxorubicin is given into a vein by a healthcare professional, in cycles, usually every few weeks. Your team sets the schedule and dose for your cancer type and product.
- Standard doxorubicin products are given into a vein, and should never be given into muscle or under the skin.
- Liposomal products such as Doxil are infused slowly at first, and are not given as a quick push or undiluted.
- Liposomal products are not to be swapped for other doxorubicin products.
Dosing details from the FDA-approved label
From the Doxorubicin prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Single agent (doxorubicin hydrochloride injection, solution)
- 60 to 75 mg/m2 as a single intravenous injection administered at 21-day intervals
- The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration
- In combination with other chemotherapy drugs (doxorubicin hydrochloride injection, solution)
- 40 to 60 mg/m2 given as a single intravenous injection every 21 to 28 days
- Early breast cancer involving axillary lymph nodes (NSABP B-15, AC regimen)
- Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 administered intravenously on day 1 of each 21-day treatment cycle
- Four cycles of treatment were administered
- Dose modifications of AC to 75% of the starting doses for neutropenic fever/infection were allowed
- Hyperbilirubinemia (plasma bilirubin 1.2 to 3 mg/dL)
- Dosage reduction 50%
- Dosage must be reduced in case of hyperbilirubinemia
- Hyperbilirubinemia (plasma bilirubin 3.1 to 5 mg/dL)
- Dosage reduction 75%
- Dosage must be reduced in case of hyperbilirubinemia
- Ovarian cancer (doxorubicin hydrochloride liposome injection)
- 50 mg/m2 intravenously over 60 minutes every 28 days until disease progression or unacceptable toxicity
- Initial rate of 1 mg/min to minimize the risk of infusion reactions; if no infusion-related reactions occur, increase rate to complete administration over 1 hour
- AIDS-related Kaposi's Sarcoma (doxorubicin hydrochloride liposome injection)
- 20 mg/m2 intravenously over 60 minutes every 21 days until disease progression or unacceptable toxicity
- Initial rate of 1 mg/min to minimize the risk of infusion reactions
- Multiple Myeloma (doxorubicin hydrochloride liposome injection)
- 30 mg/m2 intravenously over 60 minutes on day 4 of each 21-day cycle for eight cycles or until disease progression or unacceptable toxicity, administered after bortezomib on day 4 of each cycle
- Initial rate of 1 mg/min to minimize the risk of infusion reactions
Read the label’s full dosing text
DOSAGE AND ADMINISTRATION: When possible, to reduce the risk of developing cardiotoxicity in patients receiving doxorubicin after stopping treatment with other cardiotoxic agents, especially those with long half-lives such as trastuzumab, doxorubicin-based therapy should be delayed until the other agents have cleared from the circulation (see WARNINGS and PRECAUTIONS, General ). Care in the administration of doxorubicin will reduce the chance of perivenous infiltration (see WARNINGS ). It may also decrease the chance of local reactions such as urticaria and erythematous streaking. On intravenous administration of doxorubicin, extravasation may occur with or without an accompanying burning or stinging sensation, even if blood returns well on aspiration of the infusion needle. If any signs or symptoms of extravasation have occurred, the injection or infusion should be immediately terminated and restarted in another vein. If extravasation is suspected, intermittent application of ice to the site for 15 min. q.i.d. x 3 days may be useful. The benefit of local administration of drugs has not been clearly established. Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation is recommended. Blistering, ulceration and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting. The most commonly used dose schedule when used as a single agent is 60 to 75 mg/m 2 as a single intravenous injection administered at 21-day intervals. The lower dosage should be given to patients with inadequate marrow reserves due to old age, or prior therapy, or neoplastic marrow infiltration. Doxorubicin has been used concurrently with other approved chemotherapeutic agents. Evidence is available that in some types of neoplastic disease, combination chemotherapy is superior to single agents. The benefits and risks of such therapy continue to be elucidated. When used in combination with other chemotherapy drugs, the most commonly used dosage of doxorubicin is 40 to 60 mg/m 2 given as a single intravenous injection every 21 to 28 days.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Doxorubicin side effects
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Common side effects
- Tiredness and weakness
- Fever
- Nausea and vomiting
- Mouth sores (stomatitis)
- Diarrhea or constipation
- Loss of appetite
- Rash
- Hand-foot syndrome (liposomal products)
When to get medical help
- Tell your care team right away about burning, stinging, redness, or swelling at the infusion site, since leakage outside the vein can severely damage tissue.
- Get help for shortness of breath, swelling in the legs, a racing or irregular heartbeat, or sudden weight gain, which can signal heart problems.
- Report fever, chills, or signs of infection, because low white blood cell counts can lead to serious infection.
- Report unusual bleeding or bruising.
- Tell your team about chest tightness, flushing, or trouble breathing during an infusion, which may be an infusion reaction.
- Report yellowing of the skin or eyes, or other liver problems.
- Tell your doctor about severe skin changes on the hands and feet or at areas that were previously irradiated.
Common side effects include:
- Tiredness and weakness
- Fever
- Nausea and vomiting
- Mouth sores
- Diarrhea or constipation
- Loss of appetite
- Rash
- Hand-foot syndrome (liposomal products)
- Low white cells, platelets, and red cells
Call your team promptly for fever or signs of infection, bleeding, breathing trouble, leg swelling, a racing heartbeat, or pain or swelling at the infusion site.
Doxorubicin warnings and precautions
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- Heart damage: risk increases with total lifetime dose and can show up years later. Heart function is checked before, during, and after treatment.
- Tissue injury: leakage from the vein can cause blistering and severe tissue damage.
- Low blood counts: serious infection, bleeding, and anemia can occur; counts are checked before each treatment.
- Secondary leukemia: AML or MDS can develop, generally within 1 to 3 years of treatment.
- Liver problems: reduced clearance raises toxicity, so the dose is lowered.
- Radiation: doxorubicin can increase radiation toxicity and cause radiation recall.
- Tumor lysis syndrome: can occur in rapidly growing tumors.
Doxorubicin interactions
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Several drugs can raise heart risk or change doxorubicin levels.
- Trastuzumab: increases heart risk, so it should be avoided with doxorubicin and for up to 7 months before.
- CYP3A4, CYP2D6, or P-gp inhibitors: can raise doxorubicin levels and side effects.
- CYP3A4, CYP2D6, or P-gp inducers: can lower doxorubicin levels.
- Paclitaxel: raises doxorubicin levels if given first.
- Dexrazoxane: should not start with doxorubicin because of lower tumor response.
- 6-mercaptopurine: may worsen liver toxicity.
- Live vaccines: avoid because of infection risk.
Interactions listed in the FDA-approved label
From the Doxorubicin prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Inhibitors of CYP3A4, CYP2D6, or P-gp: Increased concentrations of doxorubicin, which may increase the incidence and severity of adverse reactions of doxorubicin hydrochloride. Avoid concomitant use.
- Inducers of CYP3A4, CYP2D6, or P-gp: May decrease the concentration of doxorubicin. Avoid concomitant use.
- Paclitaxel: Paclitaxel, when given prior to doxorubicin hydrochloride, increases the plasma concentrations of doxorubicin and its metabolites. Administer doxorubicin hydrochloride prior to paclitaxel if used concomitantly.
- Trastuzumab: Concomitant use results in an increased risk of cardiac dysfunction; patients receiving doxorubicin after stopping trastuzumab may also be at increased risk of cardiotoxicity, and trastuzumab may persist in the circulation for up to 7 months. Avoid concomitant administration; avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible; if anthracyclines are used before this time, carefully monitor cardiac function.
- Dexrazoxane: Initiation of dexrazoxane with doxorubicin hydrochloride-based chemotherapy resulted in a significantly lower tumor response rate (48% vs. 63%; p = 0.007) and shorter time to progression compared to doxorubicin-based chemotherapy alone. Do not administer dexrazoxane as a cardioprotectant at the initiation of doxorubicin hydrochloride-containing chemotherapy regimens.
- 6-Mercaptopurine: Doxorubicin hydrochloride may potentiate 6-mercaptopurine-induced hepatotoxicity.
Read the label’s full interactions text
7 DRUG INTERACTIONS Avoid concomitant use of doxorubicin hydrochloride with inhibitors and inducers of CYP3A4, CYP2D6, and/or P-gp ( 7.1 ). Do not administer doxorubicin hydrochloride in combination with trastuzumab due to increased risk of cardiac dysfunction ( 5.1 , 7.2 ). 7.1 Effect of Other Drugs on Doxorubicin Hydrochloride for Injection Inhibitors of CYP3A4, CYP2D6, and P-gp Concomitant use of doxorubicin hydrochloride with inhibitors of CYP3A4, CYP2D6, or P-glycoprotein (P-gp), increased concentrations of doxorubicin, which may increase the incidence and severity of adverse reactions of doxorubicin hydrochloride. Avoid concomitant use of doxorubicin hydrochloride for injection with inhibitors of CYP3A4, CYP2D6, or P-gp. Inducers of CYP3A4, CYP2D6, or P-gp Concomitant use of doxorubicin hydrochloride with inducers of CYP3A4, CYP2D6, or P-gp may decrease the concentration of doxorubicin. Avoid concomitant use of doxorubicin hydrochloride for injection with inducers of CYP3A4, CYP2D6, or P-gp. Paclitaxel Paclitaxel, when given prior to doxorubicin hydrochloride, increases the plasma-concentrations of doxorubicin and its metabolites. Administer doxorubicin hydrochloride for injection prior to paclitaxel if used concomitantly. 7.2 Concomitant Use of Trastuzumab Concomitant use of trastuzumab and doxorubicin hydrochloride results in an increased risk of cardiac dysfunction. Avoid concomitant administration of doxorubicin hydrochloride for injection and trastuzumab [see Warnings and Precautions (5.1) ]. Patients receiving doxorubicin after stopping treatment with trastuzumab may also be at an increased risk of developing cardiotoxicity. Trastuzumab may persist in the circulation for up to 7 months. Therefore, avoid anthracycline-based therapy for up to 7 months after stopping trastuzumab when possible. If anthracyclines are used before this time, carefully monitor cardiac function.
Excerpted — the section continues on the label. Read the full Drug Interactions section on DailyMed →
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Doxorubicin
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- Tell your doctor about heart disease, a recent heart attack, prior chest radiation, or earlier anthracycline treatment.
- Tell your doctor about liver disease, since severe liver impairment is a contraindication for standard doxorubicin.
- Standard doxorubicin should not be used with severe ongoing low blood counts or prior severe allergy to it.
- Avoid pregnancy and use effective contraception during treatment and afterward; it can harm a baby.
- Do not breastfeed during treatment and for 10 days after the last dose.
- It may affect fertility in women and men.
- Children need long-term heart monitoring.
Doxorubicin overdose
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Overdose cases have been rare. They caused fast heartbeat, very low blood counts, severe mouth sores, and serious infection. Patients were treated with supportive care such as growth factors and antibiotics, and recovered over a few weeks.
What Doxorubicin does in the body
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Doxorubicin kills cancer cells by damaging DNA and triggering programmed cell death. The same actions are thought to cause its toxic effects on organs. Free radical formation is linked to its heart toxicity.
How your body processes Doxorubicin
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After a vein infusion, doxorubicin spreads into tissues quickly and leaves slowly, with a terminal half-life of about 20 to 48 hours. It does not cross the blood-brain barrier. The body breaks it down mainly through metabolism (involving CYP3A4, CYP2D6, and P-gp) and clears it through bile; only a small part leaves in urine. Clearance is lower in people with raised bilirubin and in obese women.
How to store Doxorubicin
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Refrigerate unopened vials of DOXIL (doxorubicin hydrochloride liposome injection) at 2°C- 8°C (36°F- 46°F). Do not freeze.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Doxorubicin
139 supplements and herbal products have documented interactions with Doxorubicin in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 2
- Moderate · 110
- Minor · 27
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Nutrient depletion considerations
Doxorubicin has been associated with lower levels of 1 nutrient in the clinical literature. This does not mean a deficiency will occur — it means these may be worth discussing with your pharmacist or healthcare provider, especially with long-term use.
Educational information from a licensed clinical database (Natural Medicines) — not medical advice. Do not start or stop medications or supplements without professional guidance.
Doxorubicin: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Doxorubicin — the kind of thing our pharmacy team would talk through with you at the counter.
What is doxorubicin for?
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How will I receive it?
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What side effects should I expect?
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When should I call my care team?
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Can I use it while pregnant or breastfeeding?
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Do other medicines matter?
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Is Doxorubicin available over the counter?
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When was Doxorubicin first available?
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Who makes Doxorubicin?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Doxorubicin on HelloPharmacist
Doxorubicin forms and strengths (how it comes)
Doxorubicin is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Adriamycin is used with other chemotherapy after breast cancer surgery in women with lymph node involvement, and for leukemias, lymphomas, and several metastatic cancers.
- Doxil is used for ovarian cancer after platinum-based chemotherapy, AIDS-related Kaposi’s sarcoma after other chemotherapy, and multiple myeloma with bortezomib.
- Doxorubicin Hydrochloride Liposome is used for ovarian cancer, AIDS-related Kaposi’s sarcoma, and multiple myeloma with bortezomib.
- Adriamycin is given into a vein, and the infusion should be stopped right away if leakage outside the vein is suspected.
- Doxil is infused into a vein, starting slowly to reduce infusion reactions, and should not be given as a bolus or undiluted.
- Doxorubicin Hydrochloride Liposome is not to be substituted for other doxorubicin hydrochloride products.
Doxorubicin on the U.S. market: products, makers and brands
How Doxorubicin appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
30 companies list 180 Doxorubicin product records with the FDA, mostly as injection; the earliest marketing or approval year on record is 1988. Brand names on the directory include Adriamycin, Rubex, Doxil and 2 more; the rest are generics.
Also listed with the FDA, not a patient dose form: Powder (7) — bulk drug substance sold to compounders/manufacturers and multi-item kits. These aren’t counted in the dose-form total above.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
How widely Doxorubicin is used (Medicaid data)
A general measure of how commonly Doxorubicin is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Doxorubicin is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Doxorubicin prescribed? Of the 1,599 medications we measure, Doxorubicin ranks #891 by Medicaid prescriptions — more than 44% of them.
Utilization by Doxorubicin product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
doxorubicin hydrochloride 2 MG/ML Injectable Solution Most dispensed
Summed across the 6 of 31 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1191138
25 ML doxorubicin hydrochloride 2 MG/ML Injection
Summed across the 5 of 11 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790100
5 ML doxorubicin hydrochloride 2 MG/ML Injection
Summed across the 3 of 12 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790097
10 ML doxorubicin hydrochloride liposome 2 MG/ML Injection
Summed across the 6 of 23 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790115
10 ML doxorubicin hydrochloride 2 MG/ML Injection
Summed across the 3 of 9 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790099
25 ML doxorubicin hydrochloride liposome 2 MG/ML Injection
Summed across the 1 of 24 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790127
doxorubicin hydrochloride 50 MG Injection
Summed across the 1 of 3 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 1790095
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Doxorubicin, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 25 of 113 listed Doxorubicin NDCs with Medicaid activity.
Compare Doxorubicin products
A representative set of FDA-listed product records for Doxorubicin — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 2 mg/mL | Intravenous | Actavis Pharma, Inc. × 3 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Alembic Pharmaceuticals Inc. × 6 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Alembic Pharmaceuticals Limited × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Amneal Pharmaceuticals LLC × 6 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Athenex Pharmaceutical Division, LLC. | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Baxter Healthcare Company | NDA | View NDC → |
| 2 mg/mL | Intravitreal | Baxter Healthcare Company | NDA | View NDC → |
| 2 mg/mL | Intravenous | Baxter Healthcare Company × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 2 mg/mL | Intravenous | Baxter Healthcare Corporation × 6 listings | NDA | View NDC → |
| 2 mg/mL | Intravenous | Baxter Healthcare Corporation × 2 listings | UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE | View NDC → |
| 2 mg/mL | Intravitreal | Baxter Healthcare Corporation × 2 listings | NDA | View NDC → |
| 2 mg/mL | Intravenous | Baxter Healthcare Corporation × 2 listings | NDA AUTHORIZED GENERIC | View NDC → |
| 2 mg/mL | Intravenous | BluePoint Laboratories × 10 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Bryant Ranch Prepack × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Dr. Reddy's Laboratories Inc × 8 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Dr. Reddy's Laboratories Inc. × 4 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Fresenius Kabi USA, LLC × 4 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Gland Pharma Limited × 9 listings | ANDA | View NDC → |
| 2 mg/mL | — | GlaxoSmithKline Manufacturing SpA | DRUG FOR FURTHER PROCESSING | View NDC → |
| 2 mg/mL | Intravenous | Hikma Pharmaceuticals USA Inc. × 40 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Lupin Pharmaceuticals, Inc. × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Mylan Institutional LLC × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | NorthStar RxLLC × 10 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Padagis US LLC × 4 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Pfizer Laboratories Div Pfizer Inc × 28 listings | NDA | View NDC → |
| 2 mg/mL | Intravenous | Sagent Pharmaceuticals × 3 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Sun Pharmaceutical Industries, Inc. × 6 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Zydus Lifesciences Limited × 2 listings | ANDA | View NDC → |
| 2 mg/mL | Intravenous | Zydus Pharmaceuticals USA Inc. × 4 listings | ANDA | View NDC → |
| 💊Bulk drug substance | ||||
| 1 g/g | — | Gemini PharmChem Mannheim GmbH | BULK INGREDIENT | View NDC → |
| 10 g/10 g | — | Meiji Seika Pharma Co., Ltd. | BULK INGREDIENT | View NDC → |
| 600 g/600 g | — | MicroBiopharm Japan Co., Ltd. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Olon SpA | BULK INGREDIENT | View NDC → |
| 100 kg/100 kg | — | Sicor S.r.l. | BULK INGREDIENT | View NDC → |
| 1 kg/kg | — | Zhejiang Hisun Pharmaceutical Co., Ltd. × 2 listings | BULK INGREDIENT | View NDC → |
Showing 180 of 180 products — FDA National Drug Code Directory. See every product, package size and price: browse all 180 Doxorubicin NDCs →
Doxorubicin side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Doxorubicin — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Doxorubicin in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Doxorubicin FDA approval history
How Doxorubicin went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Doxorubicin recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list 2 Doxorubicin recalls since July 2021. One of them is still ongoing and is listed first. A recall names specific lots from one company, so check the lot number on your own bottle rather than assuming every product is affected; your pharmacist can check whether your supply came from an affected lot.
- DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutica… Lots: Lot HAG2581B, expires: 05/31/2027 FDA record D-0580-2026 →
- Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL), Single-Dose Vial, Rx only, Manufactured for: Baxter Healthcare Corporation, Deerfield, IL 60015. NDC 0338-0067-01 Lots: Lot# MKZSU02, Exp 6/30/2024 FDA record D-0048-2024 →
Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 3639 2 dose forms · 9 strengths
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Dose form (SCDF) Injectable Solution RxCUI 374376In current FDA listingsClinical drug / strength (SCD) hydrochloride 2 MG/MLRxCUI 1191138 -
Dose form (SCDF) Injection RxCUI 1790094In current FDA listingsClinical drug / strength (SCD) hydrochloride 10 MGRxCUI 1790103hydrochloride 20 MGRxCUI 1872062hydrochloride 50 MGRxCUI 17900955 ML doxorubicin hydrochloride 2 MG/MLRxCUI 179009710 ML doxorubicin hydrochloride 2 MG/MLRxCUI 179009910 ML doxorubicin hydrochloride liposome 2 MG/MLRxCUI 179011525 ML doxorubicin hydrochloride 2 MG/MLRxCUI 179010025 ML doxorubicin hydrochloride liposome 2 MG/MLRxCUI 1790127
Look up RxCUI 3639 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Doxorubicin supply and shortage status
Whether Doxorubicin is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Doxorubicin brand names
Doxorubicin is sold under 5 brand names in the FDA directory — Adriamycin, Rubex, Doxil, Caelyx and others. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Doxorubicin: manufacturers and labelers
30 companies list Doxorubicin products with the FDA. By number of product records, the largest are Hikma Pharmaceuticals USA Inc., Pfizer Laboratories Div Pfizer Inc, Baxter Healthcare Corporation. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
…and 6 more on the FDA NDC directory.
Doxorubicin drug class (RxNorm)
Doxorubicin belongs to the Anthracycline Topoisomerase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Doxorubicin page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amneal Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →